Penumbra System (Thunderbolt Aspiration Tubing)
Summary
Penumbra, Inc. received 510(k) clearance for Penumbra System (Thunderbolt Aspiration Tubing), a NRY device. Cleared on 2026-06-10.
Details
Source
510(k) Clearance
External ID
K250690
Action Date
2026-06-10
Status
Traditional
Category
device
Product Code
NRY
Product Description
Penumbra System (Thunderbolt Aspiration Tubing). Product code: NRY.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Penumbra, Inc. has received 20 total clearances in our database.
Penumbra, Inc. has 20 FDA actions in our database, including 20 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Penumbra, Inc. have FDA actions?
Penumbra, Inc. has 20 FDA actions in our database, including 0 recalls and 20 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K250690" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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